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Cardiovascular disease (CVD) is a global health burden and a prominent cause of death, projected to increase the world's mortality to 23 million by 2030 []. The invention of DeBakey's roller pump and its inclusion in the Cardiopulmonary Bypass (CPB) machine by Gibbon has revolutionized the field of cardiac surgery. Since then, rapid improvement and refinement accelerated the CPB technology, such as the establishment of hollow membrane fiber oxygenators followed by the advancements seen with Heparin-coated circuits, real-time monitoring, and the innovative cardioplegia and its delivery techniques derived by evolutions of computer chips and biomaterial manufacturing []. The CPB works by extracorporeal pumping of venous blood to gas exchange device and filter, regulate its temperature then returning it to the patient's arterial system to maintain blood supply to other organs during heart surgery []. Due to its complexity and time sensitivity, CPB requires highly trained perfusionists and expert cardiac surgeons, and anesthesiologists [].

Many factors contribute to the clinical success of CPB, such as blood transfusion management, hemodynamic support of the extracorporeal circulation, and pharmacotherapy strategies management, as well as perioperative control of electrolytes and blood glucose levels [,]. Despite decades of advancements in CPB regarding optimal hemodilution, heparin adjustments, and pH regulation, CPB has been linked to recognized incidence of complications []. This is mainly because of blood exposure to foreign surfaces used in the CPB circuit []. Moreover, CPB consequences may lead to an increased likelihood of fluid overload after surgery, inflammation, micro-embolic, and immune-related damage [,].

Several societies have developed standards and guidelines for CPB to ensure safe and effective patient care. To enhance the outcomes of patients undergoing heart surgery, a task force composed of experts in the field was formed to create evidence-based guidelines for CPB practice by the European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Cardiothoracic Anesthesiology (EACTA), and the European Board of Cardiovascular Perfusion (EBCP) []. The guidelines for blood, transfusion, anticoagulation, and temperature management during CPB in cardiac surgeries were established in 2007 with the collaboration of the Society of Cardiovascular Anesthesiologists (SCA) and then enhanced and revised by the American Society of Extracorporeal Technology (AmSECT), International Consortium for Evidence-Based Perfusion Committee republished in 2011 [,].

In Saudi Arabia, continuous efforts by the medical society have been made to enhance CPB management; Mohanlall et al. [], conducted a randomized, controlled clinical study at the Northwest Armed Forces Military Hospital in Tabuk, Saudi Arabia. They compared 2 types of modified ultrafiltration systems: conventional arteriovenous modified ultrafiltration (AVMUF) and a custom-designed Veno-arterial modified ultrafiltration (VAMUF) system. The study found that VAMUF was a more physiologically appropriate technique, showing significantly greater reductions in creatinine, serum lactate, and uric acid over time. Another observational study by Soliman et al. [], investigates the impact of hemofiltration during CPB on lactate levels in adult patients undergoing cardiac surgery at the Prince Sultan Cardiac Center in Riyadh. They found that hemofiltration led to hemoconcentration, elevated lactate levels, and a need for increased inotropic support. They also recommended using hemofiltration for patients with impaired renal function, positive fluid balance, or extended bypass times, more than 2 hours, minimizing fluid administration to preserve adequate cardiac output, cutting priming volumes, and performing hemofiltration either before weaning from or after CPB, rather than continuously during the procedure.

Additionally, a trial conducted at King Faisal Specialist Hospital and Research Center (KFSH&RC) by Khouqeer et al. [], investigated the validity and efficacy of adding a hemoconcentrator reservoir collection bag to the CPB circuit in 13 cardiac surgery patients. The aim of blood transfusion reduction was noticed in the 60% improvement of non-transfusion rates, reinfusing about 292 mL of salvaged blood, and maintaining stable hemoglobin levels. In the field of cardiothoracic surgery, this is the first publication of national standards and guidelines for best practice in perfusion for patients in Saudi Arabia, introducing invaluable resources to perfusionists, clinicians, cardiac anesthesiologists and surgeons, intensive care specialists, researchers, and medical care providers for improving patient outcomes during and after cardiovascular surgery. These offer pertinent knowledge of CPB and extracorporeal life support during surgery and in non-surgical situations, advising on practical clinical applications from experts in the field.

These guidelines provide evidence-based recommendations for the clinical practice of managing patients requiring cardiac perfusion care in Saudi Arabia. They focus on the monitoring and management of patients with ischemic heart diseases, heart failure, and other related conditions requiring cardiac perfusion interventions. These guidelines also address special considerations for certain patients undergoing surgical cardiac perfusion procedures. The aim is to provide evidence-based recommendations to guide healthcare professionals in managing patients undergoing cardiac perfusion interventions in Saudi Arabia, supplemented by expert consensus where appropriate.

The guideline's scope was determined through expert consensus, which includes: guidelines, protocols, and general practices: Addressing the framework for safe and effective CPB practices, highlighting optimal procedure methods. We also address the Heart-Lung Machine Hardware, providing guidance on equipment usage and maintenance, Cardioplegia and Priming Solutions, focusing on myocardial protection and preparation of the bypass circuit, Monitoring and Perioperative Management, covering some of the strategies for intraoperative and postoperative patient care.

The Saudi clinical practice guidelines for cardiac perfusion aim to: AServe as a national reference for cardiac perfusion clinical practice to suit the specific demographic needs of local populations in Saudi Arabia. Optimize guidance for various treatment modalities for managing cardiac perfusion needs in different clinical scenarios. Improve patient outcomes related to management, procedural success rates, and overall quality of life. Guide identification and management strategies to minimize the impact of cardiac perfusion-related conditions on patients' lives.

These guidelines will benefit perfusionists, anesthesiologists, cardiac surgeons, intensivists, cardiologists, general practitioners, and clinical pharmacists in Saudi Arabia. They offer valuable insights into cardiac perfusion management for healthcare decision-makers, researchers, and guideline developers. In addition, end-users might also include patients requiring cardiac perfusion interventions and their caregivers.

The Ministry of Health of Saudi Arabia aims to provide clinicians and their patients with guidelines for managing and treating conditions requiring cardiac perfusion among patients of all genders. Clinicians, patients, third-party payers, institutional review committees, and other stakeholders should interpret these recommendations as broad guidance, not absolute mandates, and definitely do not substitute sound clinical judgment and experience. In this guideline, we used the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach to state the recommendations. However, as discussed in other guidelines that follow the GRADE approach, no guideline or recommendation can encompass all the unique and often compelling aspects of individual clinical situations. Consequently, those responsible for assessing clinicians' actions should avoid applying these recommendations rigidly or uniformly without assessing the context of the scenario.

Recommendations are accompanied by statements that take into account values and preferences, resource use, feasibility, equity, acceptability, and other relevant factors. It is crucial to consider that these statements are essential for understanding the context of the recommendations. While the guideline provides valuable guidance, exercising sound clinical judgment in individual cases is essential. Clinicians should tailor their approach to unique needs and circumstances, considering the potential benefits and risks of different management strategies in their patients' overall health and well-being.

We recommend a systematic review and update of the existing guidelines one year after their publication, followed by updates every 2 years to ensure they remain relevant, accurate, and aligned with current best practices and stakeholder feedback. To enhance robustness, we also advocate for integration with a national audit registry, along with the creation of a data repository for input from end-users for collecting concerns, issues, and recent advancements pertinent and relevant to the perfusion practice in Saudi Arabia that should be addressed with the coming updates.

The guidelines were created through a collaborative process utilizing the GRADE method, which promoted transparent communication, agreement among specialists, and the consideration of various viewpoints. This method aided in minimizing bias and guaranteed that the recommendations were founded on the best available evidence. The panel was actively engaged along with the contribution authors in writing up the broad knowledge base, followed by experts' meetings to pose pertinent PICO questions and create guidelines for carrying out the review, consolidating the evidence, evaluating its dependability, and developing recommendations.

The guideline panel conducted a thorough review of recently released guidelines to pinpoint key research inquiries []. Following this, the panel deliberated on which population, intervention, comparator, and outcome (PICO) questions are vital to complement clinical practice in Saudi Arabia. Additionally, the panel had the opportunity to propose new PICO questions. After thoughtful consideration, the panel formulated 22 questions that were deemed most pertinent to clinical practice in Saudi Arabia. The guideline panel assessed and authorized the finalized list of PICO questions. For each PICO, we utilized the GRADE framework to categorize outcomes as critical, important, or not important []. The prioritized outcomes included pertinent clinical data.

The methodologists conducted a systematic literature review to update the evidence supporting previously published guidelines. They meticulously searched medical databases (PubMed and Scopus) using tailored search terms for each specific research question, with the support of experts in research methodology and medical literature. The search terms employed for each question are detailed in the supplementary of tables. All relevant systematic reviews, individual randomized controlled trials (RCTs), non-randomized trials, post hoc analyses, and pooled analyses published from 2010 to 2024 were extracted from the databases, Figure S1 . If there were no relevant ones, we included articles published before 2010. Case reports, narrative reviews, and clinical guidelines were excluded from the articles that will be applied sto the GRADEpro system. When there were insufficient direct articles that could answer the PICO questions, the experts depended on their clinical experience. Two authors independently examined the titles and abstracts of the collected citations and included studies that satisfied the inclusion criteria for each PICO question. The same reviewers reviewed titles and abstracts and recognized potentially suitable articles.

We focused on incorporating recent meta-analyses and systematic reviews in our search. However, in cases where relevant systematic reviews were unavailable or published prior to 2010, we included RCTs that related to our research questions. To evaluate the quality of these RCTs, we employed the established criteria from the Cochrane risk of bias tool to assess potential biases []. For non-RCTs, the evaluation was conducted using the Newcastle & Ottawa scale []. For every outcome, we applied the GRADE approach to evaluate the certainty of the evidence. The certainty of the evidence was categorized as high, moderate, low, or very low based on several domains: study design, risk of bias, publication bias, consistency of findings, indirectness of evidence, and imprecision of the estimate [].

For each PICO question, we utilized the GRADEpro guideline development tool [] to create evidence profiles that included evaluations of critical and important outcome absolute and relative effects, as well as certainty assessments. We applied the GRADE methodology to assess the reliability of the evidence when formulating clinical practice recommendations for cardioperfusion techniques. The GRADE method is widely used to evaluate the certainty of evidence utilized in clinical practice guidelines. This method examines 5 elements to determine the overall reliability of the evidence: “study design,” “risk of bias,” “publication bias,” “imprecision,” “inconsistency,” and “indirectness.” We displayed the outcomes and the reliability assessment of the evidence through evidence profiles. After evaluating the 5 domains of GRADE, the certainty of evidence was rated as very low, low, moderate, and high []. High certainty indicates a strong assurance that the actual effect is near the estimated effect. Moderate certainty suggests a reasonable level of confidence, with the true effect likely being similar. Low certainty signifies that the effect estimate is limited, and the true effect may vary significantly. Very low certainty denotes that the effect estimate is highly uncertain, indicating a need for additional research to diminish this uncertainty.

Each suggestion was made considering the risk-to-benefit balance, the quality of the evidence for each intervention, and the clinical expertise of the panel. The suggestions were updated during virtual meetings. The updated recommendations were submitted to the expert panel for voting using the GRADEpro system, requiring a minimum consensus of 70% to be approved. The suggestions may either support or oppose the intervention. Furthermore, the recommendations' strength is classified as either strong or conditional. Recognizing the significance of the strength of the recommendation is essential for making informed decisions, as shown in .

Cardiovascular perfusion can temporarily bypass the heart and lungs through artificial extracorporeal circulation, providing their physiological functions, including oxygenation, ventilation, and delivering blood all over the body []. CPB is a subset of cardiovascular perfusion that is performed by a perfusionist, a key player in the surgical team []. Perfusionists are responsible for operating the heart-lung bypass machine during heart surgery, providing stable circulation through the procedure []. Additionally, they maintain tissue viability through various tasks, including measuring the components of blood and ensuring appropriate mechanical, pharmacological, and thermal manipulation, consulting cardiac surgeons and anesthesiologists whenever needed []. Therefore, they are required to understand the pathophysiology of both the respiratory and circulatory systems well to make sure they are capable of handling such complex machines proficiently [,]. In addition to that, the stressful conditions of this work necessitate the perfusionist to develop coping strategies, pay attention to details, communicate well with the surgical team, and be updated with the developments in the field []. They can also be incorporated into other administrative duties, such as supply chain management and succession planning [].

High-quality and cost-effective patient care in the modern healthcare system depends on many factors, including patient needs, doctors' experience, and robust hospital structure []. One major contributor is an effective multidisciplinary team, which can ensure good management regarding complex and challenging tasks through team collaboration toward shared goals []. In high-risk settings such as the cardiac operating room (OR), this collaboration can be life-saving when encountering unexpected events, minimizing catastrophic outcomes []. Therefore, a dynamic environment, including perfusionists, surgeons, anesthesiologists, nurses, and other skilled professionals, could lead to quick decision-making and technical excellence [,]. Additionally, optimizing surgical efficiency and reducing errors alongside patient outcome enhancement can be achieved through good teamwork training alongside continuous process improvement measures such as briefings, debriefings, and root cause analyses []. In addition to that, this success can be sustained by persistent education and efforts to keep high team performance [].

These principles are responsible for ensuring optimal patient care and outcomes in cardiac surgery with CPB, including: I) Maintaining a safe minimum number of full-time equivalent accredited clinical perfusionists is needed to optimize patient care. While N+1 is the recommended standard number of perfusionists, where N equals the number of operating theaters at any given time, N+2 is recommended when the number of operating rooms exceeds or equals 4, excluding trainees from the minimum safe number []. II) On-call shifts should be customized not to exceed one in every 4 rotations to avoid overworking the staff. As such, 1 in 3 could lead to fatigue and reduced performance. Furthermore, staff should not proceed to regular day work the next day after on-call. Instead, they should get adequate rest to prevent burnout [,,]. III) Vacation periods, sick leaves, and national holidays should be considered to ensure good coverage all the time. Comfortable accommodations in the on-call rooms and staff lounges should also be provided to increase staff readiness and well-being. Subsequently, this could result in better care for patients, depending on the expected less fatigued and higher-performance staff []. The recommended full-time equivalent (FTE) for perfusion services in the Saudi workplace, as endorsed by the Ministry of Health (MOH) of Saudi Arabia is shown in detail in .

1) Technician: A staff member with foundational training in perfusion-related tasks, often assisting in setup and monitoring under supervision. 2) Specialist: A licensed clinical perfusionist responsible for independently managing CPB cases and extracorporeal systems. 3) Senior Specialist: An experienced perfusionist who takes a supervisory role, mentors junior staff, and handles complex cases or emergencies. 4) Consultant: The highest-level expert in perfusion services with leadership responsibilities, including program development, training, research, and strategic planning (Saudi Commission for Health Specialties [SCFHS], 2015).

There is a significant gap regarding perfusion schools in Saudi Arabia nowadays. Although they are absent now, they were represented by the Perfusion Undergraduate Diploma Program at the Prince Sultan Cardiac Center (PSCC) and the King Faisal Specialist Hospital (KFSH) program. The PSCC was discontinued in 2016 despite the graduation of 37 perfusionists. Additionally, the KFSH program had 22 technicians who graduated before it ended in 2012. Subsequently, the number of Saudi perfusionists is lacking today, representing only 28% of the current workforce in the country. Numerous cardiac centers are also under development, putting more burden on educating and training more perfusionists to cover these centers, alongside supporting other related services dependent on perfusion technology.

One to 4 years are required to complete training in perfusion centers, educating perfusionists with the necessary knowledge, skills, and techniques. These programs are accredited based on meeting essential standards, such as facilities and supervision. Additionally, they should be based on curriculum, such as ensuring good coverage of physiology, biochemistry, applied anatomy, pharmacology, and pathology. They should also care for soft skills, enhance team dynamics and communication, and cope with stress. After completing the program, the trained personnel should be evaluated for their knowledge, skills, and attitude by decisive tools, granting them finally the accreditation of being clinical perfusionists. Certification maintenance requires a minimum annual caseload of 75 cases and continuous professional development. Recertification can be done through the Saudi Commission for Health Specialties (SCFHS) after ensuring compliance with international standards. In addition to that, certified perfusionists must operate within a quality management framework that emphasizes standard operating procedures, risk assessments, peer reviews, and audits.

To address this gap, we recommend re-establishing structured national training programs in partnership with universities and cardiac centers, incorporating simulation-based education and mentorship pathways. A centralized framework under the SCFHS could standardize curricula, ensure sustainability, and align training with international best practices.